Associate Director, PV Scientist

Biogen; Cambridge (MA); Hybrid; USD 172,000 - 237,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs

Paid vacation and personal days

401(k) with company match

Tuition reimbursement

Employee stock purchase plan

Job summary

Biogen is looking for an Associate Director for the Safety Surveillance and Aggregate Reports group in Cambridge, MA. This hybrid role involves leading safety oversight and managing a team while ensuring compliance with global regulations.

The ideal candidate will have 10+ years in Pharmacovigilance, experience with safety signal management, and the ability to articulate complex data. The role offers a competitive salary and a range of employee benefits including health insurance and a 401(k) program.

Qualifications

• Minimum 10 years of experience in Pharmacovigilance including safety signal management.
• Experience with Global Filings and Risk Management Plans.
• Ability to present scientific data in various formats.

Responsibilities

• Serve as lead PV Scientist for products, providing strategic direction.
• Oversee signal detection and management activities.
• Lead departmental initiatives to meet strategic goals.

Skills

Pharmacovigilance experience

Safety signal management

Aggregate safety reports writing

Ability to analyze scientific data

Strong organizational skills

Job description

About This Role

As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a critical part in ensuring the safety and efficacy of our products while fostering a collaborative and high‑performing team environment.

What You’ll Do

• Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight.
• Oversee signal detection and management activities, Risk Management Plans (RMPs – core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
• Demonstrate leadership and interact collaboratively and effectively in a team environment including Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
• Respond to regulatory requests and support regulatory filing activities for topics and questions related to product safety.
• For roles with line management, manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists.
• Accountable for departmental processes, ensuring strict compliance with global PV regulations as well as process improvements.
• Lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group.

This position is Hybrid based out of our Cambridge, MA office.

Who You Are

You are deeply invested in ensuring the utmost safety for patients involved in clinical trials or using our approved treatments. You can distill complex data into clear, actionable insights and shine in a collaborative team setting. Your exceptional organization and time‑management skills enable you to thrive in a fast‑paced environment where your contributions make a significant impact on patient and public health.

Required Skills

• Minimum 10 years Pharmacovigilance experience, including safety signal management, responses to health authorities, and aggregate safety reports writing in both clinical trial and post‑marketing settings.
• Experience authoring and leading safety sections for Global Filings (e.g., US NDA, EU MAA), including the EU Risk Management Plan.
• Experience authoring signal evaluation or analysis, Risk Management Plans (RMPs – core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
• Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Strong organizational skills, with the ability to prioritize independently with minimal supervision and assess resource needs and adapt accordingly.
• Represent and speak about processes in cross‑Safety and cross‑functional forums.

Job Level

Management

Additional Information

The base compensation range for this role is: $172,000.00 – $237,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short‑term and long‑term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize future potential based on individual, business unit and company performance.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short‑ and Long‑Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end‑of‑year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

On top of the above, Biogen maintains a full and highly competitive range of additional benefits designed to support physical, financial, emotional, and social well‑being of employees and their families.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.